Status:
WITHDRAWN
Repeated Intranasal Esketamine Plus Almond Therapy in Participants With Treatment Resistant Depressive Disorder - 3 Month Extension Study
Lead Sponsor:
Zylorion Health
Conditions:
Treatment Resistant Major Depressive Disorder
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine if any improvements in depressive symptoms are maintained in the medium and longer-term (up to 3 months)
Detailed Description
The duration of the study is 3 months Participants enrolled in the Almond Therapy group will have up to 9 in person visits, including the baseline visits, participants will receive Esketamine on 8 of...
Eligibility Criteria
Inclusion
- Participants must have completed Study ZYL-730-01 through to Day 28
- Adults aged 18-64
- Participants must have a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign an informed consent.
- Women must use a medically acceptable reliable means of contraception and must agree to use adequate birth control for the duration of the study and for 6 weeks after the last dose using methods from the permitted list for contraception.
- If currently receiving medication for depression their antidepressant dose(s) must be stable for the previous 4 weeks prior to baseline.
- Must be on a stable dose of all other medication(s) for at least 1-month prior to baseline visit., unless medication is to treat other short term conditions (i.e. influenza, upper respiratory track infections, pain, etc.)
- Controlled hypertension and must be on a stable dose of antihypertensive medications for at least 3 months prior to the baseline visit.
Exclusion
- Women who plan to become pregnant, are pregnant or are breastfeeding.
- Serious unstable medical illness, or any significant change in medical status at the baseline visit and during the study, as determined by the Investigator
- Hormonal treatment (e.g., Estrogen) started within the 3 months prior to first dose of study treatment.
- Participants who report treatment with a benzodiazepine, an opioid medication, or a mood stabilizer (such as valproic acid or lithium) at the baseline visit and within 2 weeks prior to the first dose of Esketamine .
- Participants with confirmed psychotic disorder or symptoms, bipolar disorder and or clinically significant alcohol or substance misuse confirmed by a psychiatrist at the baseline visit. Those participants who develop symptoms of these may be withdrawn from the study, as determined by the Investigator
- Current diagnosis of bulimia nervosa, or development of significant eating disorder symptoms at the baseline visit or during the study as determined by the Investigator
- Participants who have been diagnosed with ADD/ADHD and who are also currently taking stimulant medication such as methylphenidate or another amphetamine-type medication, or who are diagnosed with this disorder or who start medication for this during the study.
- Participants currently taking St John's Wort, Ginseng or Turmeric who start any of these during the study
- Participants judged clinically to be actively at serious risk of self-harm or suicidal behaviour by the study team or psychiatrist at baseline or at any time during the study, as determined by the Investigator.
- Blood pressure \>140/90 at baseline
- Participants who are unable to easily travel to the clinic for all of the in-person visits.
Key Trial Info
Start Date :
January 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05438758
Start Date
January 15 2023
End Date
March 1 2024
Last Update
November 15 2022
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